FDA.reportPublic FDA data

STAT PROFILE

Primary DI
00385480336239
Brand
STAT PROFILE
Company
NOVA BIOMEDICAL CORPORATION
Model
PHOX PLUS L
Catalog number
33623
Device description
STAT PROFILE pHOx PLUS L LACTATE MEMBRANE KIT
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHPACID, LACTIC, ENZYMATIC METHOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023567000STAT PROFILE PHOX PLUS L ANALYZERNova Biomedical Corp.2002-12-20CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385480336236PackageGS12In Commercial Distribution
00385480336239PrimaryGS10
00385489336230Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038548033623610385480336236
00385480336239003854803362393854803362390385480336239
00385489336230003854893362303854893362300385489336230

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVD, portable, semi-automatedA portable mains electricity (AC-powered) laboratory instrument, which may include internal rechargeable batteries, intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with reduced technician involvement and automation of some procedural steps.

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-6682info@novabio.com

Regulatory Flags#

DUNS number
070617139
Device count
3
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00385480657365StatSensor StatStripGen 2.0657362026-05-06
00385480667678StatSensor StatStripGeen 2.0667672026-05-06
00385480667685StatSensor StatStripGen 2.0667682026-05-06
10385480632307Nova PrimaryNova Primary Glucose Membrane 632302023-02-22
00385480632317Nova PrimaryNova Primary Glucose Sensor 632312023-02-09
00385480533980STATSTRIP1.75533982016-09-20
00385480533997STATSTRIP1.75533992016-09-20
00385480547901STATSTRIP1.86547902016-09-16
00385480636858StatStrip63685636852024-03-28
10385480534939NOVAMAX PLUS KETONE534932016-09-20
00385480434355Nova MaxPlus434352016-09-20
00385480434362Nova MaxPlus434362016-09-20
00385480458245Nova MaxPlus458242016-09-20
20385480534936NOVAMAX PLUS KETONE534932016-09-20
10385480631645Nova PrimaryNova Primary Ampuled Control 1, 2631642023-02-24
10385480631652Nova PrimaryNova Primary Linearity Level 1 631652023-02-24
10385480631669Nova Primary Nova Primary Linearity Level 2631662023-02-24
00385480631648Nova PrimaryNova Primary Ampuled Control 1, 2631642023-02-24
00385480631655Nova PrimaryNova Primary Linearity Level 1 631652023-02-24
00385480631662Nova Primary Nova Primary Linearity Level 2631662023-02-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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80816042014549FORAFORA CARE INC.KHP2025-05-06
00850014861407HeartsCare LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
00850014861537HeartsCare LACTATE TEST STRIPS (25PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSKHP2024-07-01
00380740158392ARCHITECTABBOTT IRELANDKHP2024-01-24
00380740158408AlinityABBOTT IRELANDKHP2024-01-24
00816042014505FORAFORA CARE INC.KHP2023-10-31
00850014861360HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.KHP2023-08-08
06971674866756BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
06971674866763BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
06971674866770BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
00630414610979Atellica CH Lactate_3Siemens Healthcare Diagnostics Inc.KHP2023-05-10
00630414305066Atellica CH Lactate_3Siemens Healthcare Diagnostics Inc.KHP2023-05-10
10385480408131Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408141Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408158Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480626248Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
10054749005502i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
00054749005505i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
00630414606460epoc Host2Epocal IncKHP2020-07-15
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.KHP2020-04-15
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05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSKHP2018-09-21
05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSKHP2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSKHP2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSKHP2018-09-21
05700699250476925-047 ABL90 FLEX inlet clipRadiometer Medical ApSKHP2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSKHP2018-09-21